Successful completion of the first dose group in the Phase I/II study
of Amphinex® in cancer patient
(Thomson Reuters ONE) - Oslo, 19 October 2009 - PCI Biotech has completed the treatment ofthe first dose group in the phase I/II study of Amphinex® in cancerpatients. No serious adverse events have been recorded and tumourresponse was seen even at this low dose. The study is primarilyenrolling Head & Neck cancer patients and is performed at UniversityCollege Hospital (UCH) in London.This is a dose escalating study where the patients are treated withAmphinex® in combination with the cytotoxic agent bleomycin. Whenactivated by light, Amphinex® promotes effective delivery of largetherapeutic molecules such as bleomycin through triggered endosomalrelease. The first dose level of the trial is now completed. Thepatients at the next dose level have already started to sign up forparticipation in the study and will be treated with Amphinex® as soonas possible.The primary objective of this study is to assess the maximumtolerated dose of Amphinex® in PCI treatment with bleomycin.Secondary objectives include determination of the antitumor activityof Amphinex® when used in combination with bleomycin, as well as itspharmacokinetics. Preliminary results from the trial are expectedearly in 2010.Notes to editorsPCI BiotechPCI Biotech is a Norwegian biopharmaceutical company developing anovel light directed drug delivery system based on its patentedphotochemical internalisation (PCI) technology. Originating fromworld leading research at the Norwegian Radium Hospital, the PCImethod involves first injecting target cells with a photosensitiser.Therapeutic molecules are then delivered to the cells and when theseare illuminated the cells' endosomes are ruptured to allow successfuluptake.PCI can enhance the delivery of all molecules taken into the cell byendocytosis. This includes most types of macromolecules, drugscarried by antibodies or nanoparticles, as well as some smallmolecule drugs. In addition, PCI enables the use of more toxiccompounds by restricting their effects to the target site.PCI Biotech follows a dual strategy of using its technology toimprove the effect both of existing drugs and for emerging treatmentssuch as gene therapy. PCI Biotech's first clinical study couples theproven photosensitiser Amphinex® with the cytotoxic agent bleomycin.Other studies are planned for the delivery of other cancer drugs inrelevant indications.For more information visit: www.pcibiotech.comContact information:PCI Biotech Holding ASA, Hoffsveien 48, N-0377 Oslo, NorwayPer Walday, CEO, pw(at)pcibiotech.no, Mobile: +47 917 93 429Bernt-Olav Røttingsnes, CFO, bor(at)pcibiotech.no, Mobile: +47 913 47021This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 19.10.2009 - 08:36 Uhr
Sprache: Deutsch
News-ID 7046
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"Successful completion of the first dose group in the Phase I/II study
of Amphinex® in cancer patient"
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